Narcotic UseNCT03728517
Narcotics Inpatient / Outpatient
An observational study of Narcotic Use, run by Indiana University at 3 sites in United States.
Trial summary
Managing pain in postoperative patients presents challenges in striking a balance between achieving adequate pain control and over-prescribing opioids that have the potential to contribute to the opioid epidemic. There are no clear guidelines informing postoperative opioid prescribing in obstetrics and gynecology. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Narcotic Use
- How many people
- 4 participants
- Where
- 3 sitesUnited States
- Study dates
- 23 Aug 2018to 1 Jan 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Adult, Older adult
Study population: Subjects who are 18 years old or older who will have a vaginal , laparoscopic, or robotic surgery who require observation of an inpatient stay post-operatively.
Who may be able to join
- 18 years old or older
- Undergoing vaginal, laparoscopic or robotic gynecologic surgery requiring observation or inpatient stay overnight
- Agree to receiving contact from research staff for follow up
- Can provide two telephone numbers or a telephone number and email address
Who cannot join
- Unable to provide informed consent
- Age <18
- Intolerance/allergy to more than two narcotic medications
- Allergy/contraindication to non-steroidal anti-inflammatory drugs (NSAIDs)
- Has a diagnosed gynecologic malignancy other than Grade 1 endometrial cancer
- Pregnant
- Current opioid use on a regular basis (more than twice per week)
- Illicit drug-use within the past 30 days
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Eskenazi Health Hospital
Indianapolis, Indiana, 46202
Indiana University
Indianapolis, Indiana, 46202
Methodist Hospital
Indianapolis, Indiana, 46202
About this study
Official title: Comparison of Inpatient Narcotics Use to Outpatient Prescription Narcotics Post-operatively
Managing pain in postoperative patients presents challenges in striking a balance between achieving adequate pain control and over-prescribing opioids that have the potential to contribute to the opioid epidemic. There are no clear guidelines informing postoperative opioid prescribing in obstetrics and gynecology.
The primary aim for this study are to better understand the factors that impact opioid use for pain management in gynecologic surgery patient after discharge. The second aim is to develop a model that incorporates individual patient baseline measures (e.g. anxiety, fibromyalgia score, inpatient narcotic consumption) to predict the amount of opioids needed following discharge.
Read the detailed description
Managing pain in postoperative patients presents challenges in striking a balance between achieving adequate pain control and over-prescribing opioids that have the potential to contribute to the opioid epidemic. There are no clear guidelines informing postoperative opioid prescribing in obstetrics and gynecology. A recent study by As-Sanie et al. demonstrated that gynecologists at a large academic medical center prescribe twice the amount of opioids than the average patient uses after hysterectomy.1 Similarly, a study completed at Vanderbilt University Medical Center showed that obstetricians were overprescribing narcotics to patients after cesarean deliveries.2
In addition to rates of opioid prescribing, other factors affect postoperative opioid consumption, including individual patient measures of anxiety, depression, and self-reported pain scores prior to surgery. Preoperative Fibromyalgia symptom scores, STAIT state anxiety scores and NRS pain expectations are independent predictors for morphine consumption following hysterectomy.
There is a pressing need to better understand the factors that impact opioid use in women who undergo gynecologic surgery in order to mitigate the over-use of opioids for pain control upon discharge from the hospital.
Aims:
- Understand the factors that impact opioid use for pain management in gynecologic surgery patients after discharge.
- Is opioid consumption during the immediate postoperative recovery phase associated with consumption after discharge?
- Are variables that are known to be associated with opioid consumption, also associated with opioid consumption after discharge?
- Are there factors which we can use to predict opioid consumption in postoperative patients?
- Develop a model that incorporates individual patient baseline measures (e.g. anxiety, fibromyalgia score, inpatient narcotic consumption) to predict the amount of opioids needed following discharge.
- Conditions
- Narcotic Use
- Keywords
- Narcotic, Inpatient, Outpatient, Comparison
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Subjects who undergo gynecologic surgery | Subjects who will undergo gynecologic surgery via vaginally, laparoscopic , or robotic who require observation or inpatient stay overnight. This group will receive pain medication in the hospital and will also be discharged home with pain medication. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Understand the factors that impact opioid use for pain management in gynecologic surgery patients after discharge.
- Is opioid consumption during the immediate postoperative recovery phase associated with consumption after discharge?
- Are variables that are known to be associated with opioid consumption, also associated with opioid consumption after discharge?
- Are there factors which we can use to predict opioid consumption in postoperative patients?
Measured: 1 year
Secondary outcomes (1)
Develop a model
- Develop a model that incorporates individual patient baseline measures (e.g. anxiety, fibromyalgia score, inpatient narcotic consumption) to predict the amount of opioids needed following discharge.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2018
- Study start23 Aug 2018
- Primary completion1 Jan 2019
- Study completion1 Jan 2019
Why it stopped: Low recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Narcotic UseStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Insiyyah Patanwala, Indiana University
- Investigators
- Insiyyah Y Patanwala, Principal investigator, Indiana School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03728517
- Sponsor's protocol ID
- 1805708779
- Status last verified
- Apr 2019
- First submitted
- 31 Oct 2018
- Last updated
- 11 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Inpatient Narcotics Use to Outpatient Prescription Narcotics Post-operatively
- ClinicalTrials.gov ID
- NCT03728517
- Acronym / sponsor ID
- 1805708779
- Conditions
- Narcotic Use
- Keywords
- Narcotic, Inpatient, Outpatient, Comparison
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Low recruitment
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- 23 Aug 2018 (actual)
- Primary completion
- 1 Jan 2019 (actual)
- Study completion
- 1 Jan 2019 (actual)
- First posted
- 2 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Managing pain in postoperative patients presents challenges in striking a balance between achieving adequate pain control and over-prescribing opioids that have the potential to contribute to the opioid epidemic. There are no clear guidelines informing postoperative opioid prescribing in obstetrics and gynecology.
The primary aim for this study are to better understand the factors that impact opioid use for pain management in gynecologic surgery patient after discharge. The second aim is to develop a model that incorporates individual patient baseline measures (e.g. anxiety, fibromyalgia score, inpatient narcotic consumption) to predict the amount of opioids needed following discharge.
Detailed description
Managing pain in postoperative patients presents challenges in striking a balance between achieving adequate pain control and over-prescribing opioids that have the potential to contribute to the opioid epidemic. There are no clear guidelines informing postoperative opioid prescribing in obstetrics and gynecology. A recent study by As-Sanie et al. demonstrated that gynecologists at a large academic medical center prescribe twice the amount of opioids than the average patient uses after hysterectomy.1 Similarly, a study completed at Vanderbilt University Medical Center showed that obstetricians were overprescribing narcotics to patients after cesarean deliveries.2
In addition to rates of opioid prescribing, other factors affect postoperative opioid consumption, including individual patient measures of anxiety, depression, and self-reported pain scores prior to surgery. Preoperative Fibromyalgia symptom scores, STAIT state anxiety scores and NRS pain expectations are independent predictors for morphine consumption following hysterectomy.
There is a pressing need to better understand the factors that impact opioid use in women who undergo gynecologic surgery in order to mitigate the over-use of opioids for pain control upon discharge from the hospital.
Aims:
- Understand the factors that impact opioid use for pain management in gynecologic surgery patients after discharge.
- Is opioid consumption during the immediate postoperative recovery phase associated with consumption after discharge?
- Are variables that are known to be associated with opioid consumption, also associated with opioid consumption after discharge?
- Are there factors which we can use to predict opioid consumption in postoperative patients?
- Develop a model that incorporates individual patient baseline measures (e.g. anxiety, fibromyalgia score, inpatient narcotic consumption) to predict the amount of opioids needed following discharge.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects who undergo gynecologic surgery | – | –Subjects who will undergo gynecologic surgery via vaginally, laparoscopic , or robotic who require observation or inpatient stay overnight. This group will receive pain medication in the hospital and will also be discharged home with pain medication. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Subjects who are 18 years old or older who will have a vaginal , laparoscopic, or robotic surgery who require observation of an inpatient stay post-operatively.
Key inclusion criteria (4 listed)
- 18 years old or older
- Undergoing vaginal, laparoscopic or robotic gynecologic surgery requiring observation or inpatient stay overnight
- Agree to receiving contact from research staff for follow up
- Can provide two telephone numbers or a telephone number and email address
Key exclusion criteria (8 listed)
- Unable to provide informed consent
- Age <18
- Intolerance/allergy to more than two narcotic medications
- Allergy/contraindication to non-steroidal anti-inflammatory drugs (NSAIDs)
- Has a diagnosed gynecologic malignancy other than Grade 1 endometrial cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Understand the factors that impact opioid use for pain management in gynecologic surgery patients after discharge.
Time frame: 1 year
1. Is opioid consumption during the immediate postoperative recovery phase associated with consumption after discharge? 2. Are variables that are known to be associated with opioid consumption, also associated with opioid consumption after discharge? 3. Are there factors which we can use to predict opioid consumption in postoperative patients?
1 secondary outcome
Develop a model
Time frame: 1 year
Results and safety
The study was stopped early (reason given: Low recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Insiyyah Y Patanwala principal investigator
Indiana School of Medicine
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Narcotic Use, run by Indiana University at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Low recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Understand the factors that impact opioid use for pain management in gynecologic surgery patients after discharge. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2019.